JOHANNESBURG, 31 MAY 2018 – Yesterday, after nine years of development, the Department of Trade and Industry (the dti) finally published the Intellectual Property Policy of the Republic of South Africa, Phase I. The policy has been adopted by cabinet and as such represents official government policy, and has the potential to herald a new era in access to medicines for South Africa.

While we welcome the finalisation and adoption of this policy, we stress that it has not yet changed anything in the lives of people in South Africa who right now need medicines that remain unaffordable, and that it will not do so until key elements of the policy become law. As a matter of urgency, the dti must produce a thorough and far-reaching bill to amend the relevant Acts and parliament must prioritise the passing of this bill. Those aspects of the policy that can be implemented without legislative changes must be implemented right away. Whether the state can deliver the required legislative changes will be a key test of its commitment to the health of the people.

The harsh reality is that this law reform process in South Africa has already taken too long. It has taken too long for two of our comrades who have passed away in recent years, Tobeka Daki and Sue Johnson. At critical times in their illnesses, both Tobeka and Sue could not access the medicines they needed due to high prices. We will remember these comrades as we continue to advocate for more just and humane patent laws.

Comment on the content of the policy

As the Fix the Patent Laws coalition, we welcome the publication of the new policy and we are broadly in agreement with its content. The policy addresses most of the critical health-related policy and legislative changes that we have been campaigning for since 2011. We are disappointed though that certain critical sections of the policy are lacking in detail – in particular the sections on patentability criteria and on compulsory licensing.

That said, we welcome the policy’s framing in terms of the Constitution of South Africa and its acknowledgement of the importance of considering the public health impact of economic policy. We also welcome the policy’s acknowledgement that South Africa requires an intellectual property framework appropriate to its phase of development and that a patent maximalist approach is not in the best interest of our economy. In this regard, the policy implicitly rejects the incorrect view that trade-offs have to be made between the right to health and economic development.

We make the following specific comments:

We support the introduction of a substantive patent search and examination system for patents in South Africa – something we have been advocating for, for years. The policy recognises that the current depositary system, in which patent applications are granted if they meet procedural formalities (paperwork and filing fee), leads to an excessive number of poor quality patents being granted in comparison to other countries. Patent examination guidelines must now be published for public input and the examination of patent applications for pharmaceutical products must start as soon as possible.

We welcome the commitment to develop patentability criteria to “promote genuine innovation” – although we are disappointed that the policy does not go further to discourage specific evergreening practices. Ideally, the policy would have explicitly stated that South Africa will no longer grant patents for new uses, new forms, new formulations, combinations and other minor modifications of existing medicines. To improve the system, it is vital that South Africa develop rigorous patentability criteria and examination guidelines, following international best practices in countries of a similar developmental status, such as Argentina and India. By ensuring that only patents that meet rigorous criteria for novelty and inventiveness are granted, the government can curb excessive and secondary patenting, and ensure that only genuine innovation is rewarded. This will facilitate earlier introduction of more affordable generic medicines, ensuring that more people can access medicines earlier. Raising the bar for patentability is also necessary to incentivise R&D expenditure and efforts towards the development of meaningful health innovations that address unmet health needs, rather than perpetuating the pursuit of minor modifications and me-too versions of existing profitable products.

We welcome the long-term commitment to introducing pre- and post-grant patent opposition procedures that could help ensure that only those inventions that represent genuine innovation are granted patent protection. This has been another key ask of our campaign. However, we are concerned that the interim solution proposed by the policy—a third-party observation system and administrative law procedures—will not permit sufficient participation by third-parties. We instead encourage the rapid introduction of simplified opposition procedures, and greater transparency concerning patent applications to allow third parties, such as civil society groups and other pharmaceutical companies, to intervene.

We support the commitment to introduce a “more effective and efficient” system to obtain compulsory licenses for medicines – another key ask of our campaign in recent years. Compulsory licenses are a vital tool to ensure medicine access and must be available on a wide variety of grounds and in such a way that they can be granted quickly and effectively when needed for public health purposes. We urge government to withstand the industry pressure that will no doubt oppose this policy commitment, even though this commitment is entirely in line with World Trade Organisation rules.

We remain committed to engaging constructively with the DTI, the inter-ministerial committee on IP, and wider government to ensure rapid reforms to our patent laws to improve access to medicines in line with the state’s Constitutional obligations. We cannot wait another nine years for this policy to be turned into law.

The policy references the Fix the Patent Laws report that outlines key medicines that people have struggled to access as a result of patent barriers in South Africa: “Patent Barriers to Medicine Access in South Africa: A Case for Patent Law Reform”.

The Fix the Patent Laws Coalition, made up of 40 patient groups and civil society organisations representing most major diseases in South Africa was launched on 11 November 2011 (on the 10-year anniversary of the WTO Doha Declaration) to advocate for changes to South Africa’s Patent Laws.

The Fix the Patent Laws Coalition (FTPL) welcomes the news today that the Cabinet of the Government of South Africa has approved the new Intellectual Property (IP) Policy. After nine years of policy development, two different draft policies and various rounds of public consultation, we now finally have an agreed-upon government policy that can guide much-needed law reform. Though we await seeing the final policy until it is gazetted by government, we are optimistic that the policy will herald a new era for access to medicines in South Africa by prioritising people’ lives over the profits of pharmaceutical corporations.

While the finalisation and adoption of a policy is an important milestone, the hard work of developing and passing legislative amendments is still ahead of us. We urge the Department of Trade and Industry to prioritise the development of bills that will bring a more humane and Constitutionally sound balance to our legal framework.

The approval of the new IP policy is particularly poignant given that it comes just days after the loss of one of our members and brave patient activists, Sue Johnson, on 16 May 2018, to Multiple Myeloma, for which she was unable to access the recommended treatment (a medicine called lenalidomide) due to its exhorbitant cost of R75,000 per month. This same medicine is available in India for just R5,000 per month. We remember at this time also our dear colleague Tobeka Daki, who passed away in November 2016 from HER2+ Breast Cancer, and who too was unable to afford the medicine she needed – trastuzumab, which cost approximately R500,000 per course at the time. We salute these brave comrades and the many others who have not been able to get the medicines they needed as a result of South Africa’s regressive patent system.

Though we celebrate today as an important step in the right direction, we will continue the fight to fix South Africa’s patent laws until all who need affordable medicines can access them. We remain committed to a world where no-one is denied life-saving or suffering preventing treatment simply because they cannot afford it.

FTPL will release a full statement after having read and analysed the new policy in detail.

It is with immense sadness that the Fix the Patent Laws (FTPL) Coalition shares the news of the passing of a dear friend and brave patient advocate, Sue Johnson. Sue was a mother of two children and grandmother to two girls. She was born in the UK and moved to South Africa in 1983, where she spent her life working for the UN and Habitat for Humanity in Cape Town until her retirement in 2017.

Sue was also a prominent patient advocate for access to lenalidomide – a medicine prescribed for multiple myeloma – for the Cancer Alliance and FTPL. She spoke bravely and passionately of the struggles she face in accessing the medicine she needed at an affordable price, most memorably at the stakeholder meetings hosted by the Department of Trade and Industry on Intellectual Property Reform in October 2017 and at the Cancer Alliance launch of the Access to Medicine campaign in January 2018..

Sue was diagnosed with Breast Cancer in 2008 and with Multiple Myeloma in 2014. While she was initially able to access a generic lenalidomide treatment from India on a Section 21 authorisation from the Medicines Control Council at a price of about R5000 per month, this was revoked in 2016 when the originator product from Celgene, Revlimid, was registered in South Africa, at a cost of R882,000 per year. Sue’s medical insurer agreed to cover the increased cost of nearly R75,000 per month – but only for four months. After that, Sue and her family had to struggle to get the rest from their own pockets.

Secondary patents will block more affordable generics from entering the South African market until at least 2028. This means that equitable access for patients like Sue is a long way off.

“I remember that day very well, when everything changed: one day I had the support of the MCC and was able to import my medication from India. The next day the MCC took away my authorisation and my right to access generic medication. The registration of the patented product changed everything for me with just the stroke of a pen. Overnight I could no longer afford the treatment I needed to live.”

Sue will be remembered by all for her bravery and unselfish desire to fight for equitable and affordable access for all – despite knowing that she might not be able to benefit from it.

FTPL salutes Sue and will continue the fight for equitable and affordable access to lifesaving medicines for all in South Africa in her memory.

More information on lenalidomide and the battle for equitable access

With the FTPL and Cancer Alliance, Sue’s doctor, Dr Mike du Toit, appealed the MCC’s decision to deny the importation of generic lenalidomide into South Africa on the basis that the patented product was unaffordable and thereby inhibited access to patients in need of the life-saving medicine. In his appeal, Dr du Toit highlighted previous precedent of the MCC authorising the use of unregistered products on the basis of affordability concerns. The MCC’s 1 November 2017 decision to authorise importation of generic lenalidomide in response to Dr du Toit’s appeal ‘based on the previous use of the medicine and to allow for continuation of treatment’ further establishes precedent for the use of Section 21 to address affordability concerns.

A recent report by the Cancer Alliance and Fix the Patent Laws demonstrated that many important cancer medicines remain inaccessible to the majority of people that could benefit from them in South Africa while under patent due to their excessive costs. The report further highlighted that South Africa commonly grants patents that are rejected, withdrawn or overturned in other countries – blocking access to more affordable generic products already available outside of the country.

While Section 21 authorisations can improve access to generic products and should be applied more broadly for this use, the mechanism has limitations, including requiring detailed individual patient information, limiting patient numbers and, in some cases, dragging on for months or years through multiple appeal phases.

The lenalidomide case therefore further highlights the urgent need for expedited, administrative compulsory license provisions to license the use of generic products in South Africa when patents inhibit access.

On 6 November 2017, a group of US civil society organisations sent a letter urging the US government and industry not to interfere with South Africa’s efforts to promote access to lifesaving medicines. The group wrote they were “gravely concerned that the US government and industry representatives will try to undermine the South African government’s plan to reform patent laws over the next few months.” The letter notes that the draft intellectual property policy is both “consistent with South Africa’s international obligations” and “morally necessary.” It also highlights similar, existing policies in US law. The full text of the letter can be read below.

PRETORIA – Today, more than 1,000 members of the Fix the Patent Laws Coalition (FTPL) will march to the Department of Trade and Industry (dti) in support of the government’s efforts to fix our patent laws and ensure everyone has access to the medicines they need.

Made up of 36 patient groups and civil society organisations representing people affected by most major diseases in South Africa, the FTPL Coalition will hand over its in-depth submission in support of the draft Intellectual Property Policy, and a new report documenting the dire inaccessibility of many cancer medicines due to patent barriers. The draft policy was released by the dti in August 2017.

The draft policy paves the way for a new, progressive intellectual property regime in South Africa, sixteen years after the signing of the Doha Declaration on Public Health – a critical international agreement confirming countries’ ability to amend their laws to incorporate public health safeguards. Notably, for the first time, the draft policy is clear in its prioritising people’s Constitutionally guaranteed right of access to healthcare services, stating that the final policy must “first and foremost engender the ethos of the South African Constitution”.

“This reform process has been ongoing since 2009. We are encouraged that a final policy and actual changes to the law finally seem to be imminent. We march today to support the steps taken by the dti to protect public health, but also to remind the dti that people’s lives depend on the rapid conclusion of this law reform process. Until the relevant Acts are amended, people will continue to suffer and die in South Africa because they can’t access affordable medicines,” says Claire Waterhouse, Access Campaign Advocacy Adviser for Doctors Without Borders Southern Africa.

Sibongile Tshabalala, Chairperson of the Treatment Action Campaign says: “We march in solidarity with all people who cannot access the medicines they need to give them a chance at life, or to ease their suffering. We have lost comrades and friends simply because they couldn’t access the medicines they needed due to high prices driven by unwarranted patent monopolies.”

The march comes almost a year after the tragic passing of prominent FTPL activist, Tobeka Daki – a mother of two fighting HER2+ breast cancer. Daki could not access the medicine she needed, trastuzumab, due to the exorbitant price tag of almost R500,000 per year charged by pharmaceutical corporation Roche because of a protected patent monopoly.

The cancer medicines report launched today highlights that the case of trastuzumab is not unique. Of the 24 cancer medicines examined in the report, 15 are available in India for less than half of the price offered in the South African private sector.

In the most extreme case, a year’s supply of lenalidomide is priced at R882,000 in South Africa compared to less than R32,000 in India. The report confirms earlier research showing that South Africa grants large numbers of secondary patents on medicines that are often rejected in other countries – a critical factor driving the vast price differences on the same medicines in South Africa and India.

While the new medicines report highlights the serious issues in accessing many cancer treatments as a result of South Africa’s current patent laws, this is only one disease among many facing these problems. People across the country suffering from diseases ranging from HIV and TB, to epilepsy, to mental illness are all affected by similar access problems as a result of patent barriers, and it is the widespread nature of this issue that makes the finalising of patent law reforms all the more urgent.

“Luckily, it seems that the dti has woken up to the fact that it’s time to put people’s health over pharmaceutical corporation profits. The cancer report indicates just how urgent this is, which is why we want to show our support for this draft IP policy. This is South Africa’s opportunity to be a global role model in this area and we are ready to push Parliament next year to make this a reality,” says Salomé Meyer of the Cancer Alliance.

SECTION27’s Umunyana Rugege concludes: “The FTPL submission to the dti highlights areas of encouraging progress while continuing to provide recommendations for improvement, to ensure that a pro-public health policy that advances human rights is finalised.”

The Cancer Alliance and Fix the Patent Laws today launched a new medicines report that outlines 24 specific cancer medicines that people have struggled to access as a result of patent barriers in South Africa.

JOHANNESBURG, 14th AUGUST 2017 – On 8 August 2017, the Department of Trade and Industry published the Draft Intellectual Property Policy of the Republic of South Africa, Phase I, 2017. The Fix the Patent Laws Campaign (FTPL) welcomes its publication for public comment.

The FTPL, a coalition of 34 patient advocacy groups, welcomes the clear statements concerning the critical importance of advancing the Constitutionally guaranteed right of access to healthcare services. The policy points the way towards ensuring everyone in South Africa can access the medicines they need. As pointed out in the draft policy, South Africa currently grants many poor quality patents that are rejected in both other developing countries and in developed countries such as the United States. The draft policy shows an encouraging awareness that it is ultimately people in need of medicines and the South African economy that pays the price for our free-for-all patent system.

The draft policy states that the final policy must “first and foremost engender the ethos of the South African Constitution” and that a developmental and rights centred approach to IP is “urgently necessary”. We welcome the government’s commitments to cooperate to achieve the advancement of Constitutional rights and developmental goals and to do so urgently. The inter-departmental coordination between key departments, including Trade and Industry (DTI), Health, Economic Development, International Relations and Cooperation, Science and Technology and Higher Education and Training will be critical to achieving these goals as multiple departments are responsible for the legislation in need of reform. The FTPL will hold all government stakeholders to these commitments.

The draft policy identifies public health as a priority on the basis of important public interest considerations. It indicates that the DTI, together with key government departments, intends to address substantively in the immediate term, access to medicines, vaccines and diagnostics and South Africa’s approach to international IP cooperation. This policy and law reform process could thus be an important constitutional measure “to achieve the progressive realisation” of the right to health.

We welcome the DTI’s engagement with the United Nations Secretary General’s High-Level Panel on Access to Medicines report, which makes important recommendations about what states can do to ensure greater access to medicines, particularly through patent law reform.

We thank the DTI for taking account of the submissions made in respect of the IP Consultative Framework and for the substantive detail contained in this draft policy. The FTPL will study the draft policy and make comprehensive comments to assist the DTI and its government partners to implement the reforms in line with their constitutional obligations.

The following are preliminary views on the draft policy:

We support the implementation of a system of substantive search and examination of patent applications in order to ensure compliance with existing law and to ensure that only applications deserving of patent protection are granted. We agree with the proposed incremental approach, which we submit can be achieved by starting with the pharmaceutical sector and by considering outsourcing of the examination of applications for patents.

We support the recommendation to introduce pre- and post-grant opposition procedures in our law. We agree that such procedures are beneficial in that they ensure that the patent examiner has access to relevant information concerning the patent application. Third parties, which could include generic companies and civil society groups, will be able to assist the patent examiner in the decision-making process. We encourage an administratively cost-effective procedure and wide access to information concerning patent applications to enable third parties to intervene. We will make detailed submissions on potential interim procedures to enable such interventions as early as possible.

We welcome the commitment to develop patentability criteria in line with the state’s “constitutional obligations, developmental goals and public policy priorities” as well as the intention to utilise available flexibilities to strike the correct balance between promoting innovation and protecting the rights of IP holders and users (patients). We hope that this stated intention will lead to fewer poor quality or ever-greening patents being granted in South Africa and that instead only true innovations will be rewarded with patent protection.

We support the recommendations to introduce non-judicial, cost effective and expeditious mechanisms to obtain medicines through the issuance of compulsory licences. In this regard, we support the recommendation to remove the requirement that a government department first negotiate terms of a licence before approaching a court to seek a compulsory licence. This is not required by the TRIPS Agreement and should be removed through the necessary amendments to the Patents Act.

Unlike countries like Argentina, Brazil and India, South Africa has to date not taken sufficient advantage of the public health flexibilities available to it in international law in order to promote public health. This draft policy provides an opportunity that should not be squandered. It has taken 20 years of stalled policy processes to get to this point. If South Africa wishes to lead on this issue, as is expressed in the policy, the policy must be finalised with the necessary urgency and draft bills must be published with equal urgency so that the people can directly benefit from greater access to medicines for cancer, tuberculosis, HIV, mental health conditions, hepatitis, epilepsy, and many other diseases.

Many people in South Africa continue to die and suffer because they cannot access the medicines that they need. This policy provides hope to those people. It is now up to government to deliver on this promise by swiftly implementing wide-ranging law reform in line with this policy.

The FTPL will publicly share its submission and its full views on the draft policy. We encourage other stakeholders to publicly state their positions on the proposals in the draft policy. Comments are open for 60 days from the date of publication of the draft policy in the Government Gazette.

On 7 June 2017, the FTPL coalition sent letters to all government ministers who form part of South Africa’s cabinet asking them to urgently finalise the draft intellectual property policy. The draft policy has been delayed in cabinet for more than 2 months, while people living in South Africa still struggle to access the medicines they need affordably, as a result of existing archaic patent laws. Enough is enough!

JOHANNESBURG, 13 JUNE 2017: The Fix the Patent Laws coalition welcomes the Competition Commission’s announcement earlier today that they will investigate the pricing of several cancer medicines in South Africa. This is a major victory in our struggle to ensure that all people in South Africa can access the medicines they need to stay healthy and alive.

Earlier this year our coalition launched the Tobeka Daki Campaign for Access to Trastuzumab during a global day of action. The campaign was named after Tobeka Daki – a fearless comrade and cancer activist who died of breast cancer in November 2016. Even though Tobeka’s doctor thought she should be provided trastuzumab, Tobeka could never access the medicine due to its high price – over half a million rand per treatment course in the private sector.

The Competition Commission probe announced today will investigate the price of cancer medicines of three pharmaceutical companies. One of these companies is Roche Holdings AG, which will be investigated for the excessive pricing of trastuzumab (the medicine Tobeka never had the chance to try). The investigation specifically relates to “excessive pricing”, “exclusionary conduct”, and “price discrimination”. While Tobeka was unable to access this medicine, Roche made USD 8.9 billion profit in 2015.

The Commission will also investigate local pharmaceutical company Aspen Pharmacare for alleged “abuse of dominance”. Reports in April this year indicated that the Spanish Markets and Competition Commission initiated anti-trust proceedings against Aspen. In October 2016, Aspen was fined over EUR 5 million by the Italian Competition Authority for having abused its dominant position by increasing prices of four of its anti-cancer medicines by up to 1,500%.

The Commission also initiated an investigation against pharmaceutical company Pfizer Inc. for “suspected excessive pricing of lung cancer medication”.

We are encouraged by the Commission’s undertaking to investigate manufacturers of excessively priced cancer medicines. We will be monitoring the Commission’s progress for the duration of these investigations. We are committed to assisting the Commission in their investigation and to ensure that cancer survivors and people who have lost loved ones to cancer have a place at the table. These investigations give hope that more people living with cancer will in future be able to access the medicines that will give them a chance at life.

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For more information and to arrange interviews contact:

Luvo Nelani | nelani@section27.org.za | 079 381 8521

The Fix the Patent Laws coalition was founded in November 2011 by the Treatment Action Campaign (TAC), Doctors without Borders (MSF) and SECTION27. Today the coalition has 34 member organisations – including the Cancer Alliance and its various member groups working on cancer-related issues. The coalition has for several years now called on the Department of Trade and Industry to finalise a policy on intellectual property that would ensure that the right to access healthcare is prioritised over the private interests of pharmaceutical companies – as required by the Constitution of South Africa. You can read more about the campaign at www.FixThePatentLaws.org

In South Africa, the annual price charged by Roche for trastuzumab in the private sector is around USD 38 365 (ZAR 516,700). The few public facilities which can access trastuzumab do so at a lower price of around USD 15 735 (ZAR 211,920) per year. But, health economists have shown that a year’s worth of trastuzumab can be produced and sold for only USD 240, a price that includes a 50% increase above the cost of production for profit.

About the Campaign

Fix the Patent Laws is a campaign co-founded by SECTION27, Treatment Action Campaign (TAC) and Doctors Without Borders (MSF) in 2011. Since then, the coalition has grown to include 38 other organisations fighting together to push South Africa to amend its patent laws to prioritise public health. Through this blog we will highlight how amending South Africa’s Patents Act 57 of 1978 will reduce the cost of medicines, improving the health and saving the lives of millions of South Africans.